Deworming and Vitamin A (DEVTA) Prepilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-04-30

Study Completion Date

1996-12-31

Brief Summary

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Background. More than a third of the world's population is infected with intestinal nematodes. A majority of these infections occur in children. Current control approaches emphasise treatment of school age children, and there is a lack of information on the effects of deworming preschool childrenSetting: Within the Integrated Child Development System (ICDS) infrastructure in urban Lucknow (UP), IndiaDesign: Open Labeled randomised trialHypothesis: Our study hypothesis was that albendazole administration six monthly, as a single 400 mg dose in syrup, by the existing health care delivery system would be a practicable way to achieve mass deworming of preschool children and this might result in an improvement in weight gain of preschool childrenIntervention One group will receive usual health care by the existing health care staff, which included six monthly administration of Vitamin A concentrate. The other group will receive, in addition, 400 mg of albendazole (Zentel, Smith Kline \& Beecham) in 10 ml syrup form. Five such doses will be given at six monthly intervals for 2 years.Main objective: To assess the impact of 6 monthly deworming on weight and height gain at the end of 2 years in children aged 1 to 5 years of age Main outcomes measures: Weight gain in 2 yearsInclusion criteria: Children 1 to 5 years, whose guardians give written informed consent. Exclusion criteria: Those not consentingSample size: Sample size was calculated for a continuous outcome. For a standardized effect size of 0.1, with a power of 80% and an alpha level of 0.05, using a 2-tailed t test, taking into account design effect, about 2000 children will be included in each arm.

Detailed Description

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Conditions

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Malnutrition Worm Infestation Under-Fives

Keywords

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Deworming Malnutrition children Community India

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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Albendazole (400 mg) and/or Vitamin a

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Local residents
* Aged 1-5 years
* Informed written parental consent

Exclusion Criteria

* Refusal to give consent
* prior enrollment in the study

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Shally Awasthi, MD, DNB

Role: PRINCIPAL_INVESTIGATOR

Dept of Pediatrics, King George's Medical University, Lucknow, India

Locations

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Lucknow Commission

Lucknow, Uttar Pradesh, India

Site Status

Countries

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India

References

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Awasthi S, Peto R, Pande VK, Fletcher RH, Read S, Bundy DA. Effects of deworming on malnourished preschool children in India: an open-labelled, cluster-randomized trial. PLoS Negl Trop Dis. 2008 Apr 16;2(4):e223. doi: 10.1371/journal.pntd.0000223.

Reference Type DERIVED

PMID: 18414647 (View on PubMed)

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id